Qualitätsmanager/in und Regulatory Affairs (m/w/x)

Responsibilities

Our client, a confidential medical device manufacturer, is seeking a Quality Manager and Regulatory Affairs professional to join their team in Iffezheim. In this role, you will:

• Manage internal quality management systems and processes
• Maintain and develop technical documentation for medical devices
• Prepare for and conduct audits with notified bodies and regulatory authorities
• Perform supplier audits and internal quality audits
• Support international product registration activities
• Contribute to product development projects
• Serve as the interface between quality assurance and production departments

What We're Looking For

The ideal candidate will bring:

• Several years of experience in a similar quality management or regulatory affairs position within a medical device company or at a notified body
• Excellent knowledge of ISO 13485 requirements and the Medical Device Regulation (EU 2017/745)
• Strong project management capabilities
• Excellent communication skills in German
• Experience working with regulatory authorities and notified bodies

How We Work With You

When you apply through Get A Job.ai, our talent team will review your profile and conduct an initial screening. If your qualifications align with our client's needs, we will submit your application to them on your behalf. Please do not contact the client directly—all communication will be managed through our recruiting team to ensure a professional and coordinated process.

The client offers attractive working conditions and flexible work arrangements.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Opportunity: Get A Job.ai is committed to inclusive hiring practices and welcomes applications from all qualified candidates regardless of background.